The PREVAILS study, now fully enrolled, marks a critical step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system

Venus Medtech (Hangzhou) Inc. (02500.HK) has completed patient enrollment in its confirmatory clinical trial for the Venus-PowerX Transcatheter Aortic Valve System. This achievement advances the world's first self-expanding dry-valve TAVR device that allows full release and complete retrieval even after 100 percent deployment, bringing it closer to market approval in China and Europe.

The Venus-PowerX PREVAILS study is a prospective, multicenter, single-arm trial that uses objective performance criteria to assess the safety, efficacy, and device performance of the Venus-PowerX system in patients with severe aortic stenosis. Results from this study will support simultaneous regulatory submissions for CE marking in Europe and approval by China's NMPA.

Venus-PowerX features several innovative technologies that set it apart from existing TAVR platforms:

100 Percent Retrievable After Full Deployment
Venus Endura Dry Tissue with Anti-Calcification Treatment
Wire-Controlled Release Mechanism
Seadapt Self-Adaptive Anti-PVL Skirt
V-Shaped Outflow Design
Three Radiopaque Markers

Venus-PowerX has already received regulatory approvals in Argentina, Chile, and Venezuela, establishing it as the world's first commercially available fully recoverable self-expanding dry-valve TAVR product. Real-world clinical data from Latin America, especially Argentina and Chile, are generating evidence that supports wider clinical use and the company's plan to introduce Chinese structural heart solutions to global markets.

"The successful completion of enrollment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVR portfolio," said Mr. Ma Renzheng, Chief Technology Officer of Venus Medtech. "We are committed to offering patients with severe aortic stenosis a more precise, safer, and more controllable treatment option, and to advancing structural heart intervention from partially controllable to fully controllable at every step of the procedure."

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (2500.HK) is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has developed a comprehensive product pipeline covering all four heart valves - TAVR, TPVR, TMVR, and TTVR - and related accessory products. With global R&D centers in China, the United States, and Israel, the company is committed to providing effective treatment solutions for life-threatening diseases.